Exosomes in Patients With Ocular Involvement of Sjögren's Syndrome

Официальное название

Exploratory Clinical Trial of Exosomes in Patients With Ocular Involvement of Sjögren's Syndrome

Обзор

This study is a single-center, multiple-dosing, prospective, nonrandom, single-arm trial.

Подробное описание

This study is a single-center, multiple-dosing, prospective, nonrandom, single-arm trial. To evaluate the clinical safety and efficacy of exosomes in patients with ocular involvement of Sjögren's syndrome.

Вмешательства

• Препарат Exosome Preparation
  Each subject will have a single designated study eye; this eye will receive multiple instillations-one drop four times daily for 14 consecutive days.

Первичные конечные точки

• Adverse events (AEs) [Срок оценки: from subjects receiving administration to Day 29 post-administration]

Вторичные конечные точки (4)

• CFS [Срок оценки: from baseline to Day 8, Day 15 and Day 29 post-administration]
• TBUT [Срок оценки: from baseline on Day 8, Day 15 and Day 29 post-administration]
• OSDI [Срок оценки: from baseline on Day 8, Day 15 and Day 29 post-administration]
• Schirmer's test [Срок оценки: from baseline on Day 8, Day 15 and Day 29 post-administration]

Критерии участия

Критерии включения

• Aged 18-65 years old, including the boundary value, no gender restriction;
• Subjects meeting the 2016 ACR/EULAR classification criteria for Sjögren's syndrome, and also meet the diagnostic criteria for ocular involvement.
• The ocular involvement symptoms and signs of these patients cannot be relieved after at least 3 months of conventional therapy, including artificial tears and topical or systemic corticosteroids.
• Extra-ocular manifestations of Sjögren's syndrome clinically stable.
• Subjects and their partners agree to use effective non-pharmacological contraception from screening through 6 months after the last dose and have no plans for conception during this period.
• Willing to participate in the study, understand and sign the informed consent form (ICF).

Критерии исключения

• Known allergy to any component of the investigational drug.
• Active ocular infection.
• Presence of other significant ocular disease or trauma diagnosed prior to enrollment, including but not limited to glaucoma, uveitis, retinopathy, chemical injury, or thermal burns.
• History of any ocular surgery within the preceding 6 months, including cataract surgery.
• Participation in another interventional clinical study.
• Use of any ophthalmic medication that may interfere with the study outcomes, such as other stem-cell-derived products.
• Having serious underlying diseases of the heart, brain vessels, liver, kidneys, and hematopoietic system.
• Pregnant or lactating women; women of childbearing potential must employ an effective contraceptive method (e.g., intrauterine device, oral contraceptive, or condom) during the study and for at least 3 months after the final dose of study drug.
• Subjects deemed unsuitable for participation in this trial by the investigator.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07192666 · PLKR-MSC-Exos-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗